Data collection apparatus for attachment to an injection device

ABSTRACT

A data collection device including an attachment assembly for attaching the data collection device to a dose setting dial of a medicament administration device, a light source configured to illuminate a portion of a surface of an internal component of the medicament administration device including a pattern of relatively reflective and non-reflecting regions formed on the surface of the internal component, and an optical sensor configured to receive light reflected by at least the relatively reflective regions.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.17/133,149, filed on Dec. 23, 2020, which is a continuation applicationof U.S. application Ser. No. 16/331,656, filed on Mar. 8, 2019, which isthe national stage entry of International Patent Application No.PCT/EP2017/072618, filed on Sep. 8, 2017, and claims priority toApplication No. EP 16188182.6, filed on Sep. 9, 2016, the disclosures ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a data collection device forattachment to an injection device and collecting medicament dosageinformation therefrom.

BACKGROUND

A variety of diseases exists that may require regular treatment byinjection of a medicament. Such injection can be performed by usinginjection devices, which are applied either by medical personnel or bypatients themselves. As an example, type-1 and type-2 diabetes can betreated by patients themselves by injection of insulin doses, forexample once or several times per day. For instance, a pre-filleddisposable insulin pen can be used as an injection device.Alternatively, a re-usable pen may be used. A re-usable pen allowsreplacement of an empty medicament cartridge by a new one. Either penmay come with a set of one-way needles that are replaced before eachuse. The insulin dose to be injected can then for instance be manuallyselected at the insulin pen by turning a dosage knob and observing theactual dose from a dose window or display of the insulin pen. The doseis then injected by inserting the needle into a suited skin portion andpressing the dosage knob or an injection button of the insulin pen.

SUMMARY

A first aspect provides a data collection device. The device includes anattachment assembly for attaching the data collection device to a dosesetting dial of a medicament administration device.

The device includes a light source configured to illuminate a portion ofa surface of an internal component of the medicament administrationdevice including a pattern of relatively reflective and non-reflectingregions formed on the surface of the internal component. The deviceincludes an optical sensor configured to receive light reflected by atleast the relatively reflective regions.

A second aspect provides a system. The system includes a medicamentadministration device. The medicament administration device includes adose setting dial. The medicament administration device includes aninternal component that rotates around a longitudinal axis of the devicewhen a dose of medicament is delivered from the device. The internalcomponent includes a pattern of relatively reflective and non-reflectingregions formed on a surface thereof, and the data collection deviceaccording to the first aspect.

A third aspect provides a system. The system includes a medicamentadministration device. The medicament administration device includes adose setting dial. The medicament administration device includes aninternal component that rotates around a longitudinal axis of the devicewhen a dose of medicament is delivered from the device. The internalcomponent includes a pattern of relatively reflective and non-reflectingregions formed on a surface thereof, and a data collection devicecomprising. The data collection device includes an attachment assemblyfor attaching the data collection device to the dose setting dial, alight source configured to illuminate a portion of the surface of theinternal component including the pattern of relatively reflective andnon-reflecting regions, and an optical sensor configured to receivelight reflected by at least the relatively reflective regions.

The light source and the optical sensor can be supported on a side ofthe data collection device which abuts the dose setting dial of the drugdelivery device. The attachment assembly can be configured to releasablyattach the data collection device to the dose setting dial of themedicament administration device such that the dose setting dial of themedicament administration device is disposed in a light path between thelight source, portion of the surface of the internal component andoptical sensor.

The light source and optical sensor can be located proximally of thedose setting dial when the data collection device is attached to thedose setting dial such that the light path between the light source,internal component and optical sensor passes through a proximal endsurface of the dose setting dial. The light source and optical sensorcan be located between the attachment assembly and the dose setting dialwhen the data collection device is attached to the dose setting dialsuch that the light path between the light source, internal componentand optical sensor passes through a side surface of the dose settingdial.

The dose setting dial of the medicament administration device can be atleast partially transmissive to electromagnetic radiation emitting bythe light source. The electromagnetic radiation can be Infrared light.

The data collection device of the first or second aspect can include anelectronics assembly including the light source and the optical sensor.The electronics assembly can be configured to move longitudinallyrelative to the attachment assembly. The dose setting dial of themedicament administration device can include a dose delivery button. Theelectronics assembly can be configured to abut the dose delivery buttonwhen the data collection device is attached to the dose setting dial andto cause depression of the dose delivery button when the electronicsassembly is moved longitudinally in a distal direction relative to theattachment assembly.

The light source and optical sensor can be located proximally of thedose delivery button when the data collection device is attached to thedose setting dial such that the light path between the light source,internal component and optical sensor passes through the dose deliverybutton. The light source and optical sensor can be located on anunderside of the electronics assembly.

The pattern of relatively reflective and non-reflecting regions caninclude evenly spaced relatively reflective and non-reflecting regionsformed on a proximal end surface of the internal component.

The light source and optical sensor can be located between theattachment assembly and the dose setting dial when the data collectiondevice is attached to the dose setting dial such that the light pathbetween the light source, internal component and optical sensor passesthrough the dose setting dial. The light path between the light source,internal component and optical sensor can pass through a part of thedose delivery button.

The pattern of relatively reflective and non-reflecting regions caninclude evenly spaced relatively reflective and non-reflecting regionsformed on an outer circumferential surface of the internal component.

The data collection device of the first or second aspect can include anelectronics assembly including the light source and the optical sensor.The electronics assembly and the attachment assembly can be fixedlyconnected together. The electronics assembly can be configured to abut aproximal end surface of the dose setting dial when the data collectiondevice is attached to the dose setting dial. The electronics assemblycan be configured to abut a circumferential surface of the dose settingdial when the data collection device is attached to the dose settingdial.

The light source and optical sensor can be located proximally of thedose setting dial when the data collection device is attached to thedose setting dial such that the light path between the light source,internal component and optical sensor passes through the dose settingdial. The light source and optical sensor can be located on an undersideof the electronics assembly.

The light source and optical sensor can be located between theattachment assembly and the dose setting dial when the data collectiondevice is attached to the dose setting dial such that the light pathbetween the light source, internal component and optical sensor passesthrough the dose setting dial.

The data collection device of the first or second aspects can include aprocessor arrangement configured to receive signals from the opticalsensor and to detect the occurrence of a medicament delivery from themedicament administration device. The processor arrangement can beconfigured to determine, from the signals received from the opticalsensor, an amount of rotation of the internal component.

The data collection device of the first or second aspect can include aswitch configured to be triggered by application of a force to aproximal end of the data collection device and wherein triggering of theswitch may be configured to cause activation of at least the lightsource, optical sensor and processor arrangement. The switch can be amechanical switch. The switch can be an optical wake-up sensorconfigured to sense the reflectance and/or colour of an underlyingcomponent of the medicament administration device and to provide awake-up signal when a change in the reflectance and/or colour isdetected.

The data collection device of the first or second aspect can include atimer and the switch can be further configured to trigger activation ofthe timer. The data collection device of the first or second aspect canbe further configured to determine an elapsed time since the timer waslast triggered and to generate an alert if the elapsed time isinconsistent with a threshold condition.

The processor arrangement can be configured to determine a time stampfor the administration of the medicament dosage using said timer and tostore the determined medicament dosage and said time stamp. Theprocessor arrangement can be configured to transmit a log of determinedinternal component rotation angles and time stamp information to anotherdevice.

The medicament administration device can include a housing and the dosesetting dial does not rotate relative to the housing when a dose ofmedicament is delivered from the device. The internal component caninclude a number of equally spaced crenellations and wherein therelatively reflective regions may be formed on the upper surfaces of thecrenellations. The light source can be an infrared light source andcomponents of the medicament administration device disposed in the lightpath between the light source and the optical sensor can be completelyor partially transmissive to infrared light. The processor arrangementcan be configured to detect the occurrence of two separate medicamentdeliveries and to amalgamate the two medicament deliveries when it isdetermined that the two deliveries occurred within a predetermined timeof each other.

A fourth aspect provides a data collection device releasably attachableto a medicament administration device. The data collection deviceincludes a sensor arrangement adapted to detect signals related to adose amount and generated during dose dialing and/or dose ejection fromsaid medicament administration device, and a processor adapted todetermine dose amounts or rotation angels based on the detected signals.The data collection device is designed to be attachable to a doseselection element of said medicament administration device and thesensor arrangement is supported on an inner surface of a mountingcomponent of said data collection device facing the dose selectionelement when attached to said medicament administration device.

In general, any component which is located close to the dose settingdial and which rotates when a dose is dispensed from the injectiondevice can be used as the internal component having the pattern ofrelatively reflective and non-reflective regions formed on a surfacethereof. Certain embodiments describe a data collection device having alight source and sensor arrangement configured to abut the dose dial(including a release button if present) when attached to an injectiondevice. The light source and sensor are configured to emit and detectradiation that can pass through material without requiring a cutout,aperture or the like, thus preventing ingress of dirt. One example forthe suitable radiation is Infrared light.

A fifth aspect provides a data collection device. The device includes anattachment assembly for attaching the data collection device to a dosesetting dial of a medicament administration device, and an electronicsassembly comprising a non-contact sensor configured to detect rotationof an internal component of the medicament administration device. Theinternal component is configured to rotate when a dose is delivered fromthe medicament administration device.

The internal component of the medicament administration device caninclude one or more magnets or magnetic areas and the non-contact sensormay be a magnetic sensor configured to detect a change in a magneticfield when the internal component is rotated.

BRIEF DESCRIPTION OF THE DRAWINGS

Example embodiments will now be described with reference to theaccompanying figures, of which:

FIG. 1 shows an exploded view of an injection device for use with a datacollection device;

FIG. 2 depicts a data collection device, attached to the injectiondevice of FIG. 1 ;

FIG. 3 is a cross-sectional view of a data collection device whenattached to a first type of injection device;

FIG. 4 illustrates an alternative arrangement for the components of adata collection device;

FIG. 5 illustrates a further alternative arrangement for the componentsof a data collection device;

FIG. 6 is a cut-away view of a second type of injection device to whicha data collection device may be attached;

FIG. 7 shows a cross-sectional view of a data collection when attachedto the injection device of FIG. 6 ;

FIG. 8 is a block diagram of the data collection device;

FIG. 9 shows a system in which the data collection device is connectedto another device, such as a personal computer; and

FIG. 10 illustrates a further alternative arrangement for the componentsof a data collection device.

DETAILED DESCRIPTION

In the following disclosure, embodiments will be described withreference to an insulin injection device. The present disclosure ishowever not limited to such application and may equally well be deployedwith injection devices that eject other medicaments.

FIG. 1 is an exploded view of a medicament administration device. Inthis example, the medicament administration device is an injectiondevice 1, such as Sanofi's AllStar® insulin injection pen, however thepresent invention is also compatible with other types and makes ofinjection pens as described below.

The injection device 1 of FIG. 1 is a pre-filled injection pen thatcomprises a housing 10 and contains an insulin container 14, to which aneedle 15 can be affixed. The injection device 1 may be disposable orre-usable. The needle is protected by an inner needle cap 16 and eitheran outer needle cap 17 or an alternative cap 18. An insulin dose to beejected from injection device 1 can be programmed, or ‘dialled in’ byturning a dosage knob 12 (also referred to herein as a dose selectionelement 12), and a currently programmed dose is then displayed viadosage window 13, for instance in multiples of units. For example, wherethe injection device 1 is configured to administer human insulin, thedosage may be displayed in so-called International Units (IU), whereinone IU is the biological equivalent of about 45.5 micrograms of purecrystalline insulin (1/22 mg). Other units may be employed in injectiondevices for delivering analogue insulin or other medicaments. It shouldbe noted that the selected dose may equally well be displayeddifferently than as shown in the dosage window 13 in FIG. 1 .

The dosage window 13 can be in the form of an aperture in the housing10, which permits a user to view a limited portion of a number sleeve 70that is configured to move when the dosage knob 12 is turned, to providea visual indication of a currently programmed dose. Alternatively, thenumber sleeve 70 can remain stationary during the dose dialling phase,and the dosage window 13 may move as a dose is dialled in to reveal thenumber corresponding to the dialled dose. In either case, the numbersleeve 70 may be a component which rotates when a dose is beingdispensed from the injection device 1.

In this example, the dosage knob 12 includes one or more formations 71a, 71 b, 71 c that facilitate programming because they improve the gripa user feels when grasping the dosage knob 12. In another example (notshown) the dosage knob does not include formations.

Attaching a data collection device does not require the dosage knobhaving formations. Having a tight fit and/or using rubber-like materialat the contact surface between the data collection device and theinjection device can provide an attachment that, on the one hand,facilitates a stable connection in the sense that the two devices remainattached to each other and, on the other hand, allows the two devices tobe separated when intended. The rubber-like material would ensure aproper fit even on a smooth surface, e. g, a dosage knob having a smoothsurface such that that rotation of the data collection device causesrotation of the dosage knob and vice versa.

The injection device 1 can be configured so that turning the dosage knob12 causes a mechanical click sound to provide acoustical feedback to auser. The number sleeve 70 mechanically interacts with a piston ininsulin container 14. When needle 15 is stuck into a skin portion of apatient, and then injection button 11 is pushed, the insulin dosedisplayed in display window 13 will be ejected from injection device 1.When the needle 15 of injection device 1 remains for a certain time inthe skin portion after the injection button 11 is pushed, a highpercentage of the dose can be injected into the patient's body. Ejectionof the insulin dose can also cause a mechanical click sound, which ishowever different from the sounds produced when using dosage knob 12. Insome other embodiments, the injection device 1 does not have a separateinjection button 11 and a user depressed the entire dosage knob 12,which moves longitudinally relative to the housing 10, in order to causethe medicament to be dispensed.

In the various embodiments, during delivery of the insulin dose, thedosage knob 12 is turned to its initial position in an axial movement,that is to say without rotation, while the number sleeve 70 is rotatedto return to its initial position, e.g. to display a dose of zero units.

Injection device 1 can be used for several injection processes untileither the insulin container 14 is empty or the expiration date of themedicament in the injection device 1 (e.g. 28 days after the first use)is reached.

Furthermore, before using injection device 1 for the first time, it maybe necessary to perform a so-called “prime shot” to remove air frominsulin container 14 and needle 15, for instance by selecting two unitsof insulin and pressing injection button 11 while holding injectiondevice 1 with the needle 15 upwards. For simplicity of presentation, inthe following, it will be assumed that the ejected amounts substantiallycorrespond to the injected doses, so that, for instance the amount ofmedicament ejected from the injection device 1 is equal to the dosereceived by the user. Nevertheless, differences (e.g. losses) betweenthe ejected amounts and the injected doses may need to be taken intoaccount.

FIG. 2 is a perspective view of one end of the injection device 1 when adata collection device 20 according to an example embodiment isattached. The data collection device 20 includes a housing 21 with anend plate 22 forming a user interaction surface. The housing 21 cansupport an optical user feedback such as one or more LEDs (not shown).In some optional embodiments, the data collection device 20 comprises adisplay (not shown). The data collection device 20 is compatible with anumber of existing injection devices 1. The data collection device 20 iscompatible with injection devices having a separate dose delivery buttonor an integrated dial. The data collection device 20 is compatible withinjection devices where the dose setting dial does not rotate duringdose administration, but where an internal component close to the dosesetting dial does rotate during dose administration. The data collectiondevice 20 allows the rotation of this internal component to be detectedand measured.

FIG. 3 is a cross-sectional view of the data collection device 20according to some embodiments, when attached to a first type ofinjection device 1.

In these embodiments, the injection device 1 is of a type having a dosesetting dial 12 with a depressible dose delivery button 11, which a userwould normally depress in order to activate the dispensing mechanism.The dose setting dial 12 is configured to be rotated to set a dose.

In some injection devices, rotation of the dose setting dial 12 causesan internal spring to be tensioned, or the device may have apre-tensioned spring. In some implementations, the dose setting dial 12does not move longitudinally during dose setting. The dose setting dial12 remains stationary during dose dispensing. For some other injectiondevices rotation of the dose setting dial 12 also causes the dosesetting dial to move proximally out of the housing 10. When a dose isdispensed from the injection device 1, the dose setting dial moves back(distally) into the housing, but does not rotate. In either case, aninternal component 70, such as a number sleeve 70, rotates during dosedispense. The data collection device 20 is configured so as to detectand measure the rotation of this internal component 70 when attached tothe injection device 1.

The data collection device 20 includes a housing 21, an electronicsassembly 24 disposed inside the housing 21 and a button 26 whichprotrudes from the proximal end of the housing 21 and is moveablelongitudinally with respect to the housing 21. The housing 21 includesan attachment assembly 23 configured to secure the data collectiondevice 20 to the dose setting dial 12. The formations 71 a, 71 b, 71 con the dose setting dial 12 may be used to facilitate attachment of thedata collection device 20.

In this particular example, the attachment assembly 23 is a sleeve thatis positioned over the dose setting dial 12 through formations, notshown, that co-operate with the formations 71 a, 71 b, 71 c on the dosesetting dial 12 so that, when the dose setting dial 12 rotates duringprogramming of the dosage, the data collection device 20 also rotates.Alternatively, or additionally, resilient padding, such as a foam rubberpad 44, can be provided within the formations on the attachment assembly23, to allow for tolerances in the dimensions of the formations on theattachment assembly 23 and the formations 71 a, 71 b, 71 c on the dosesetting dial 12 and/or to provide an engagement between the attachmentassembly 23 and the dose setting dial 12 so that rotation of theattachment assembly 23 causes rotation of the dose setting dial 12 andvice versa. In some implementations, the attachment assembly 23 includesa resilient padding of sufficient thickness to render formations thatco-operate with the formations 71 a, 71 b, and 71 c on the dose settingdial. The padding is soft enough to conform to the surface of the dosesetting dial 12. For example, the padding is soft enough to conform tothe formations on the surface of the dose setting dial 12.

The electronics assembly 24 is retained within the housing 21 such thatit can move longitudinally with respect to the housing 21. The distalside of the electronics assembly 24 is configured to abut the dosedelivery button 11 when the data collection device 20 is attached to theinjection device. The proximal side of the electronics assembly 24 abutsor is integral with the button 26. The button 26 and electronicsassembly 24 can form a single subassembly. The attachment assembly 23can form another subassembly. In this embodiment the two subassembliesare able to move longitudinally relative to each other, but cannotrotate relate to each other. The button 26 provides the finger rest forthe user and the push surface for transmitting a push force to the dosedelivery button 11 of the injection device. The result of thisconfiguration is that when the button 26 of the data collection device20 is depressed, the force is transferred through the electronicsassembly 24 to the dose delivery button 11, causing it to be depressed.

The electronics assembly 24 comprises a PCB 28 and a battery 30, forexample in the form of a coin cell. The PCB 28 may support a number ofcomponents including a processor arrangement 50, a light source 32 andan optical sensor 34. In these embodiments, the light source 32 is anInfrared light source and the optical sensor 34 is an Infrared opticalsensor. As shown in FIG. 3 , in some embodiments, the light source 32and optical sensor 34 are supported on the side of the PCB which abutsthe dose delivery button 11. The dose delivery button 11 is transparentor substantially transparent to Infrared radiation. Thus the lightemitted by the light source 32 passes through the dose delivery button11 and illuminates the internal components. In particular the numbersleeve 70 is a hollow cylinder which extends to the proximal end of thehousing 10 and is releasably fixed to the dose setting dial 12. Theannular end surface of the number sleeve 70 therefore sits underneaththe dose delivery button 11 and is illuminated by the Infrared light.The number sleeve 70 is provided with a pattern of relatively reflectiveand non-reflective regions on the annular end surface. For example,equally spaced and equally sized reflective and non-reflective sectionsmay be arranged alternately. During a dose dispensing operation, thelight source 32 illuminates the part of the number sleeve 70 includingthe pattern of relatively reflective and non-reflecting regions; and theoptical sensor 34 receives the light reflected by at least therelatively reflective regions. As the dose delivery button 11 isdepressed by the electronics assembly 24 during dose dispensing, thedistance (light path) between the light source 32 and optical sensor 34is shorter than during dialing. The output of the optical sensor 34 isrelayed to the processor 50 which calculates an amount of rotation ofthe number sleeve 70 during the dose dispensing operation. From theamount of rotation, the delivered dose can be calculated. This may bedone by the data collection device 20 or by another computing device. Ingeneral, any component which is located close to the dose setting dialand which rotates when a dose is dispensed from the injection device 1may be used as the internal component having the pattern of relativelyreflective and non-reflective regions formed on a surface thereof.

FIG. 4 illustrates an alternative arrangement for the components of thedata collection device 20. In this embodiment, the electronics assemblyis integral with or supported on an internal surface of the attachmentassembly 23 and is configured to remain substantially stationaryrelative to the attachment assembly. The button 26 of the datacollection device 20 has an elongate portion 27 which extends through anaperture 29 in the proximal end face of the data collection device. Theelongate portion 27 is configured to contact the dose delivery button 11of the injection device 1 and to transfer force form the button 26 tothe dose delivery button 11. As in the previous embodiment, the lightsource 32 and optical sensor 34 are arranged so as to face the dosedelivery button 11, which is partially or completely transparent toinfrared radiation. The light path between the light source 32,reflective regions of the number sleeve 70 and optical sensor 34 may beextended in this embodiment and suitable optical elements may beemployed to focus the light.

An advantage of the embodiment of FIG. 4 is the simple mechanical designand construction and that the subassembly (button 26) that transmits thepush force to inject is minimized. This increases user comfort asfriction is reduced and less mass needs to be moved by the user. As aresult, triggering an injection requires a relatively small amount ofadditional force from the user.

An advantage of the embodiment of FIG. 3 is that the optical path isminimized when a dose detection is being performed, as the electronicsassembly 24 directly abuts the dose delivery button 11. The optical pathin FIG. 3 may be reduced with respect to the optical path in FIG. 4 (inwhich the electronics assembly is integral with or supported on aninternal surface of the attachment assembly 23). In the embodiment ofFIG. 4 , certain enhancers may be used to improve the signal-to-noiseratio due to the longer optical path between the light source, sensorand reflective surface. For example a stronger light source 32 or moresensitive optical sensor 34 may be used. The enhancers may alternativelyor additionally be implemented as one or more collector lenses to focusthe light beam and/or baffles at the sensor 34 to blind-out scatteredlight/radiation. The enhancers are however optional.

FIG. 5 illustrates another alternative arrangement for the components ofthe data collection device 20. In this embodiment, the light source 32and optical sensor 34 are supported in a recess between the dose settingdial 12 and an internal surface of the attachment assembly 23. Forexample, the light source 32 and optical sensor 34 may be supported on aprotrusion of the electronics assembly 24. The attachment assembly 23may have a recess to allow space for this protrusion. In thisembodiment, the relatively reflective and non-reflective regions aredisposed on an outer surface of the number sleeve 70, around thecircumference. Such an arrangement may allow the reflective andnon-reflective regions to be larger or spaced further apart as morespace is available on this surface of the number sleeve 70. In thisembodiment, the light path between the light source 32, reflectiveregions of the number sleeve 70 and optical sensor 34 passes through thedose setting dial 12. Therefore, at least the annular side wall of thedose setting dial 12 is partially or completely transparent to Infraredradiation. As can be appreciated from FIG. 5 , the light path may alsopass through a portion of the dose delivery button 11, since the dosedelivery button 11 may extend into the dose setting dial 12 in order toconnect with the dispensing mechanism of the injection device 1. Thus,this portion of the dose delivery button 12 may also be transparent toIR radiation.

This embodiment may allow the optical path to be minimized and to remainunchanged when the dose delivery button 11 is depressed. This adds toincreased dose detection reliability. This embodiment also has a simplemechanical design and construction. The attachment assembly 23 of thisembodiment may have a wider diameter compared to that of FIGS. 3 and 4to allow room for the light source 32 and optical sensor 34. This mayreduce the force needed by the user to rotate the dose setting dial 12during dose dialing and therefore improve the ease of use for users withreduced dexterity.

Referring to FIG. 10 , an alternative embodiment is shown. In thisembodiment, instead of having a light source and optical sensor, theelectronics assembly comprises a non-contact magnetic sensor 80, forexample a Hall sensor. In this embodiment, the rotatable component 70comprises a series of magnetic regions 82 and non-magnetic regions 84spaced alternately around the circumference of the rotatable component70. The magnetic regions 82 may be permanent magnets, such as regionscontaining magnetic particles or a magnetic ink. As the magnetic andnon-magnetic regions, 82, 84, rotate past the magnetic sensor 80 duringdose dispense, the magnetic sensor 80 detects a periodic change in thestrength and optionally direction of the magnetic field. Thisinformation can then be used to determine the amount (angle) of rotatingof the rotatable component 70. The dose setting dial 12 is transmissiveor partially transmissive to the magnetic field generated by themagnetic regions 82, allowing the magnetic sensor 80 to detect rotationof the rotatable component 70 remotely and without the need for acut-out or aperture in the dose setting dial 12. Although FIG. 10 showsthe magnetic sensor 80 arranged radially relative to the dose settingdial 12, the magnetic sensor 80 may instead by located proximally of thedose setting dial 12, in the same manner as shown in FIGS. 3 and 4 .

FIG. 6 is a cut-away view of a second type of injection device 1 towhich the data collection device 20 may be attached. In this embodiment,the injection device 1 has a dose setting dial 12 (also referred toherein as a dose selection element 12), but does not have a separatedose delivery button, e.g. the dose setting dial may also function asthe dose delivery means when depressed.

The dose setting dial 12 is configured to be rotated to set a dose. Thiscauses the dose setting dial 12 to move proximally out of the housing10. When a dose is dispensed from the injection device 1, the dosesetting dial 12 moves back (distally) into the housing but does notrotate. As with the embodiments described with respect to FIGS. 3-5 , aninternal component 70, such as a number sleeve 70, rotates during dosedispense. The data collection device 20 is configured so as to detectand measure the rotation of this internal component 70 when attached tothe injection device 1. The injection device 1 shown in FIG. 6 may alsohave other components which rotate when a dose is dispensed, such as adrive sleeve 72. In the embodiment shown, the drive sleeve 72 has aseries of crenellations at its proximal end. The relatively reflectiveregions may be printed or otherwise deposited directly onto the uppersurfaces of these crenellations. In general, any component which islocated close to the dose setting dial and which rotates when a dose isdispensed from the injection device 1 may be used as the internalcomponent having the pattern of relatively reflective and non-reflectiveregions formed on a surface thereof.

FIG. 7 shows a cross-sectional view of the data collection device 20according to some embodiments, when attached to the injection device 1of FIG. 6 . The data collection device 20 comprises an attachmentassembly 23 and an electronics assembly 24, which may be integral orotherwise fixedly secured together. For example, the attachment assembly23 may form part of a housing 21 of the data collection device 24, andthe housing 21 may also retain the electronics assembly 24.

The attachment assembly 23 is configured to secure the data collectiondevice 20 to the dose setting dial 12. As previously described, the datacollection device 20 may employ a simple friction fit to releasablysecure it to the dose setting dial 12 and the formations 71 a, 71 b, 71c on the dose setting dial 12 may be used to facilitate attachment orangular alignment.

When the data collection device 20 and injection device 1 are securedtogether, the electronics assembly 24 is configured to abut the dosesetting dial 12. The data collection device 20 effectively replaces thedose setting dial, as the user interacts directly with the datacollection device 20 in the same way as they would with the dose settingdial to set and deliver a dose of medicament.

The electronics assembly 24 comprises numerous components including aPCB 28, the light source 32, the optical sensor 34, a processorarrangement and a battery 30. In the embodiment shown in FIG. 7 , thelight source 32 and the optical sensor 34 are supported on the distalside of the electronics assembly 24 such that they are adjacent to theproximal end face of the dose setting dial 12. The light source 32 andsensor 34 are hence supported on a side of the data collection devicewhich abuts the dose dial of the drug delivery device when attachedthereto.

In these embodiments, the light source 32 is an Infrared light sourceand the optical sensor 34 is an Infrared optical sensor. The dosesetting dial is transparent or substantially transparent to Infraredradiation. Thus the light emitted by the light source 32 passes throughthe dose setting dial and illuminates the internal components. Inparticular the number sleeve 70 is a hollow cylinder which extends tothe proximal end of the housing 10 and moves longitudinally with thedose setting dial 12 when a dose is set. The number sleeve may bereleasably fixed to the dose setting dial 12 such that the annular endsurface of the number sleeve 70 is sits underneath the dose deliverybutton 11 and is illuminated by the Infrared light of the light source32. The number sleeve 70 is provided with a pattern of relativelyreflective and non-reflective regions on the annular end surface. Forexample, equally spaced and equally sized reflective and non-reflectivesections may be arranged alternately. Alternatively, the drive sleeve 72or another internal component may be provided with the pattern ofrelatively reflective and non-reflective regions.

During a dose dispensing operation, the light source 32 illuminates aportion of the number sleeve 70 including a portion of the pattern ofrelatively reflective and non-reflecting regions; and the optical sensor34 receives the light reflected by at least the relatively reflectiveregions as they pass underneath. The output of the optical sensor 34 isrelayed to the processor 50 which calculates an amount of rotation ofthe number sleeve 70 during the dose dispensing operation. From theamount of rotation, the delivered dose can be calculated. This may bedone by the data collection device or by another computing device.

In general it is necessary to know the type of the injection device 1 towhich the data collection device 20 is attached in order to determine adose of medicament which has been dispensed. Therefore, in someembodiments, the data collection device 20 measures only the amount ofrotation of the internal component in degrees. This information is savedin a memory of the data collection device 20 and may be communicated bythe data collection device 20 to an external computing device where itis combined with information about the type of injection device 1 inorder to record the delivered medicament dose.

Similar to the embodiment described above with reference to FIG. 5 , thelight source 32 and optical sensor 34 may instead be supported in arecess between the dose setting dial 12 and an internal surface of theattachment assembly 23. For example, the light source 32 and opticalsensor 34 may be supported on a protrusion of the electronics assembly24. The attachment assembly 23 may have a recess to allow space for thisprotrusion. In such embodiments, the relatively reflective andnon-reflective regions are disposed on an outer surface of the numbersleeve 70, around the circumference. This may have the advantage overthe previously described embodiments of allowing the reflective andnon-reflective regions to be larger or space further apart as more spaceis available on this surface of the number sleeve 70. In theseembodiments, the light path between the light source, reflective regionsof the number sleeve and optical sensor passes through the annual sidewall of the dose setting dial 12, which is partially or completelytransparent to Infrared radiation. In all of the embodiments, the lightsource 32 and the optical sensor 34 are supported on a part of the datacollection device which abuts the dose dial 12 (which may include a dosedelivery button 11) of the drug delivery device 1 either radially orproximally when attached thereto.

In a further alternative embodiment (not shown), the electronicsassembly is integral with or supported on an internal surface of theattachment assembly 23 and is not configured to move relative to theattachment assembly. This is similar to the embodiment shown in FIG. 4 .However, in this alternative, the light source 32 and optical sensor 34may instead be supported on side of the electronics assembly 24 suchthat they are adjacent to the radial end face of the dose setting dial12. This embodiment provides the benefits of having a simple mechanicaldesign and enabling the reading of radial code.

The fixed construction and design of the embodiment of the datacollection device 20 in FIG. 7 has the advantage of a simple mechanicalconstruction (e.g., by minimizing relative movements) which provides anaccurately defined positioning of optical sensor 34 relative to theinjection device housing and the internal component including thepattern of relatively reflective and non-reflecting regions (e.g., dosedial 12) according to this embodiment.

A further alternative (not shown) is a modification of the embodimentshown in FIG. 7 , however the light source 32 and optical sensor 34 areinstead supported on a side of the electronics assembly 24 such thatthey are adjacent to the radial end face of the dose setting dial 12.This embodiment also provides a simple mechanical design and enables thereading of radial codes.

The data collection device of the present disclosure attaches directlyto the dose setting dial of the medicament administration device.Previous data collection devices have attached to the main housing ofthe medicament administration device. This can impede the use of themedicament administration device by a user. Many such devices attachover a dose indication window in the housing of the medicamentadministration device. This obscures the dose indication window, makingthe user wholly reliant on the data collection device to indicate thedialed dose, which may reduce user confidence in the medicamentadministration device. Some other such devices require an additional cutout or aperture in the housing of the medicament administration devicein order to view or connect with an internal moveable component. Cuttingout a part in the housing of the medicament administration device makesthe ingress of dust and dirt inside the delivery mechanism more likely.It may also present problems relating to the sterility of the medicamentadministration device.

The data collection device of the present disclosure is able to monitorthe amount of medicament dispensed from the medicament administrationdevice remotely, without contacting or being secured to the main housingof the medicament administration device. The data collection device isconfigured to attach to and to effectively replace the part of themedicament administration device with which the user would normallyinteract. When a user wishes to dial a dose, they grasp and rotate thehousing 21 of the data collection device 20 which in turn rotates thedose setting dial 12. The user can continue to observe the mechanicaldose indication window 13 of the medicament administration device. Whenthe user wishes to inject a dose, they exert a force on the proximal endof the data collection device. This in turn communicates a force to thedose setting dial. Where the medicament administration device has a dosedelivery button 11, the button 26 of the data collection device isconfigured to depress relative to the housing 21 and therefore todepress the dose delivery button 11 in turn. Therefore a user wouldnotice no material difference in the way in which they operate themedicament administration device as a result of the addition of the datacollection device according to the present invention.

The data collection device of the present disclosure may use infraredlight as an illumination source. This allows the external components ofthe medicament administration device to be made out of a plastic orother material which is opaque to optical wavelengths, but transparentor partially transparent to Infrared wavelengths. No additional cut out,aperture or the like are required, although only the appropriate areasof the medicament administration device may be made of the IRtransmissive material, effectively forming an Infrared ‘window’.

The relatively reflective and non-reflective regions of the pattern maybe printed, deposited, etched or otherwise created directly onto thenumber sleeve 70 or other suitable internal component during thatcomponent's manufacture. In some examples, the internal component islocated in close proximity to the dose setting dial. The medicamentadministration device may then be assembled in the same way as before,using the same assembly method and tools. Therefore, only very minimalmodification of the medicament administration device design and creationmay be required in order to implement the invention.

As discussed above in relation to FIG. 10 , the light source 32 andoptical sensor 34 in FIG. 7 may instead be replaced with a magneticsensor 80. The relatively reflective and non-reflective regions of thepattern on the rotatable component 70 may be replaced by alternatingmagnetic regions 82 and non-magnetic regions 84 such that when therotatable component 70 is rotated during a dose dispensing operation,there is a periodic change in the magnetic field detected by themagnetic sensor 80.

FIG. 8 is a block diagram of the data collection device 20. The datacollection device 20 includes a processor arrangement 50 including oneor more processors, such as a microprocessor, a Digital Signal Processor(DSP), Application Specific Integrated Circuit (ASIC), FieldProgrammable Gate Array (FPGA) or the like, together with memory units52 a, 52 b, including program memory 52 a and main memory 52 b, whichcan store software for execution by the processor arrangement 50. Thedata collection device includes the Infrared light source 32 and theInfrared optical sensor 34. The processor arrangement 50 controlsoperation of the light source 32 and the optical sensor 34 and receivessignals from the optical sensor 34.

The data collection device 20 has a power source 54 which may be abattery, for example a coin cell. The data collection device 20 mayoptionally include a switch 53 configured to be triggered when orshortly before a dose is dispensed. To this end, the switch 53 mayinclude a pressure or touch sensitive area in the end plate 22 or button26 of the data collection device 20, for example a piezoelectric switch.The switch 53 may control application of power from the power source 54to the processor arrangement 50 and other components of the datacollection device 20. In embodiments in which the electronics assembly24 and attachment assembly 23 are configured to move longitudinallyrelative to each other, the switch 53 may be implemented mechanically.For example, electrodes may be disposed on an internal surface of theattachment assembly 23 and corresponding electrodes on the electronicsassembly 24 may make contact (and hence complete a circuit) when thebutton 26 is depressed. This may then trigger the wake-up of the otherelectronics, including the light source and optical sensor.

Alternatively, the wake-up switch may be implemented optically as an“optical wake-up sensor”. In particular, the dose delivery button 11 ofthe injection device 1 may be coloured, for example green, while theunderlying rotatable component 70 may be white (or black). When the dosedelivery button 11 is depressed, it moves in front of the opticalwake-up sensor and the change in reflectance and/or colour can bedetected, providing the wake-up signal for the other electronics. Thischange in reflectance or colour can also be used to determine the startand end times of an injection process. In this case a switch asdescribed before may function to wake-up the electronics, including thelight source and optical sensor and an optical switch may use the changein reflectance or colour to determine start and end times of aninjection process. This could be helpful in determining if an injectionprocess has occurred or if a priming process has occurred. Further, thecolour/reflectance switch could be used to determine how long the buttonhas been pressed and use this to see if a dwell time has been respectedby the user.

A timer 55 is also included. The processor arrangement 50 may use thetimer 55 to monitor a length of time that has elapsed since an injectionwas completed, determined using the switch 53. Also optionally, theprocessor arrangement 50 may compare the elapsed time with apredetermined threshold, to determine whether a user may be attemptingto administer another injection too soon after a previous injection and,if so, generate an alert such as an audible signal and/or generate anoptical signal such as blinking one or more LEDs. The data collectiondevice 20 may comprise a number of LEDs or other light sources forproviding optical feedback to a user. For example, the LEDs may usedifferent colours and/or lighting patterns such as blinking withconstant or changing periodicity. On the other hand, if the elapsed timeis very short, it may indicate that the user is administering amedicament amount as a “split dose”, and the processor arrangement 50may store information indicating that a dosage was delivered in thatmanner. In such a scenario the elapsed time is compared with apredetermined threshold in the range of a few seconds, e.g. 10 secondsup to a few minutes, e.g. 5 minutes. According to an example thepredetermined threshold is set to 2 minutes. If the time elapsed sincethe last injection is two minutes or less, the processor arrangement 50stores information indicating that the dosage was delivered as a “splitdose”.

Another optional purpose for monitoring the elapsed time by theprocessor arrangement 50 is to determine when the elapsed time haspassed a predetermined threshold, suggesting that the user might haveforgotten to administer another injection and, if so, generate an alert.

The processor is further configured to store data relating to dateand/or time information, data relating to information from the opticalsensor 34, or combinations thereof. In particular, the memory isconfigured to store a combination of date and/or time information andinternal component rotation information retrieved from the opticalsensor 34 output data. In this way the memory is able to store a logthat provides a history of information on number sleeve 70 (or otherinternal component) rotation. Data can for example be stored in the mainmemory 52 b. Alternatively, data may be stored is a separate datastorage section (not shown) of the memory.

Since the number sleeve or other internal component rotates asmedicament is expelled from the injection device 1, the angle ofrotation measured by the optical sensor 34 is proportional to the amountof medicament expelled. It is not necessary to determine a zero level oran absolute amount of medicament contained in the injection device 1. Inthis way the sensor arrangement is less complex than compared to asensor arrangement that is configured for absolute position detection.Moreover, since it is not necessary to monitor the numbers or tick markson the number sleeve 70 displayed through the dosage window 13, the datacollection device 20 may be designed so that it does not obscure thedosage window 13.

An output 57 is provided, which may be a wireless communicationsinterface for communicating with another device via a wireless networksuch as wi-fi, Bluetooth®, or NFC, or an interface for a wiredcommunications link, such as a socket for receiving a Universal SeriesBus (USB), mini-USB or micro-USB connector. FIG. 9 depicts an example ofa system in which the data collection device 20 is connected to anotherdevice, such as a personal computer 60, via a wireless connection 61 fordata transfer. Alternatively or in addition, the data collection device20 may be connected to another device via a wired connection. Forexample, the processor arrangement 50 may store determined number sleeve70 rotation angles and time stamps (including date and/or time) for theinjections as they are administered by the user and subsequently,transfer that stored data to the computer 60. The computer 60 may beconfigured to calculate an administered dose based on furtherinformation entered by the user or a medical professional regarding thetype of injection device and the type of medicament. The computer 60maintains a treatment log and/or forwards treatment history informationto a remote location, for instance, for review by a medicalprofessional.

According to some embodiments, the data collection device 20 may beconfigured to store data such as number sleeve 70 rotation angles andtime stamps of up to 35 injection events. According to a once-dailyinjection therapy this would be sufficient to store a treatment historyof about one month. Data storage is organized in a first-in first-outmanner ensuring that most recent injection events are always present inthe memory of the data collection device 20. Once transferred to acomputer 60 the injection event history in the data collection device 20will be deleted. Alternatively, the data remains in the data collectiondevice 20 and the oldest data is deleted automatically once new data isstored. This way the log in the data collection device is built up overtime during usage and will always comprise the most recent injectionevents. Alternatively, other configuration could comprise a storagecapacity of 70 (twice daily), 100 (three months) or any other suitablenumber of injection events depending on the therapy requirements and/orthe preferences of the user.

In another embodiment, the output 57 may be configured to transmitinformation using a wireless communications link and/or the processorarrangement 23 may be configured to transmit such information to thecomputer 60 periodically.

The specific embodiments described in detail above are intended merelyas examples of how the present invention may be implemented. Manyvariations in the configuration of the data collection device 20 and/orthe injection device 1 may be conceived.

In particular, while the embodiments above have been described inrelation to collecting data from an insulin injector pen, it is notedthat embodiments of the disclosure may be used for other purposes, suchas monitoring of injections of other medicaments. Although the datacollection device has been described primarily as comprising a singleInfrared light source 32, the data collection device may comprise aplurality of light sources 32. The plurality of light sources 32 may besupported at different positions on the electronics assembly 24 and/orthe attachment assembly 23 and may be angled and or focused so as toilluminate a particular part of the internal component 70 from aparticular angle when the data collection device is attached to the dosesetting dial.

In some implementations, the data collection device 20 includes adisplay (not shown), which could for example occupy the end plate 22 ofthe data collection device 20. Various information can be displayed,such as the length of time that has elapsed since an injection wascompleted, and warning messages where a user is attempting to administeranother injection too soon after a previous injection.

The invention claimed is:
 1. A data collection device comprising: an attachment assembly for attaching the data collection device to a dose setting dial of a medicament administration device, the dose setting dial disposed at a proximal end of the medicament administration device; a light source configured to illuminate a portion of an internal component of the medicament administration device, the internal component comprising a plurality of reflective regions formed on the internal component; and an optical sensor configured to receive light reflected by the plurality of reflective regions, wherein the light source and optical sensor are configured to be located proximally of the dose setting dial when the data collection device is attached to the dose setting dial such that a light path between the light source, internal component, and optical sensor passes through a proximal end surface of the dose setting dial.
 2. The data collection device according to claim 1, wherein the light source and the optical sensor are supported on a part of the data collection device configured to abut the dose setting dial of the medicament administration device.
 3. The data collection device according to claim 1, wherein the attachment assembly is configured to releasably attach the data collection device to the dose setting dial of the medicament administration device.
 4. The data collection device according to claim 1, wherein the dose setting dial of the medicament administration device is at least partially transmissive to electromagnetic radiation emitting by the light source.
 5. The data collection device according to claim 4, wherein the electromagnetic radiation is infrared light.
 6. The data collection device according to claim 1, wherein the data collection device comprises an electronics assembly comprising the light source and the optical sensor.
 7. The data collection device according to claim 6, wherein the electronics assembly is configured to abut a dose delivery button of the medicament administration device when the data collection device is attached to the medicament administration device and to cause depression of the dose delivery button when the electronics assembly is moved longitudinally in a distal direction relative to the attachment assembly and wherein the light path between the light source, internal component and optical sensor passes through the dose delivery button.
 8. The data collection device according to claim 6, wherein the electronics assembly and the attachment assembly are fixedly connected together.
 9. The data collection device according to claim 8, wherein the electronics assembly is configured to abut the proximal end surface of the dose setting dial when the data collection device is attached to the dose setting dial.
 10. The data collection device according to claim 1, wherein the data collection device comprises a processor arrangement configured to receive one or more signals from the optical sensor and to detect an occurrence of a medicament delivery from the medicament administration device.
 11. The data collection device according to claim 10, wherein the processor arrangement is configured to detect occurrences of two separate medicament deliveries and to amalgamate the two separate medicament deliveries when it is determined that the two separate medicament deliveries occurred within a predetermined time of each other.
 12. The data collection device according to claim 10, wherein the processor arrangement is configured to determine, from the one or more signals received from the optical sensor, an amount of rotation of the internal component.
 13. The data collection device according to claim 10, wherein the data collection device further comprises a switch configured to be triggered by application of a force to a proximal end of the data collection device and wherein the switch is configured to, in response to being triggered, cause activation of at least the light source, optical sensor, and processor arrangement.
 14. The data collection device according to claim 13, wherein the switch is an optical wake-up sensor configured to sense a reflectance and/or colour of an underlying component of the medicament administration device and to provide a wake-up signal when a change in the reflectance and/or colour is detected.
 15. The data collection device according to claim 13, wherein the data collection device further comprises a timer, the switch is configured to trigger activation of the timer and wherein the data collection device is further configured to determine an elapsed time since the timer was last triggered and to generate an alert if the elapsed time is inconsistent with a threshold condition.
 16. The data collection device according to claim 15, wherein the processor arrangement is configured to: determine a time stamp for an administration of a medicament dosage using the timer and to store the determined medicament dosage and said time stamp and transmit a log of determined internal component rotation angles and time stamp information to another device.
 17. A system comprising: a medicament administration device comprising: a dose setting dial disposed at a proximal end of the medicament administration device; and an internal component that rotates around a longitudinal axis of the medicament administration device when a dose of medicament is delivered from the medicament administration device, wherein the internal component includes a plurality of reflective regions, and a data collection device comprising: an attachment assembly for attaching the data collection device to the dose setting dial; a light source configured to illuminate a portion of the internal component including the plurality of reflective regions; and an optical sensor configured to receive light reflected by the plurality of reflective regions, wherein the light source and optical sensor are located proximally of the dose setting dial when the data collection device is attached to the dose setting dial such that a light path between the light source, internal component, and optical sensor passes through a proximal end surface of the dose setting dial.
 18. The system according to claim 17, wherein the light source and the optical sensor are configured to be supported on a part of the data collection device which abuts the dose setting dial of the medicament administration device.
 19. The system according to claim 17, wherein the plurality of reflective regions comprises evenly spaced reflective regions formed on a proximal end surface of the internal component.
 20. The system according to claim 17, wherein the light source and optical sensor are configured to be located between the attachment assembly and the dose setting dial when the data collection device is attached to the dose setting dial such that the light path between the light source, internal component, and optical sensor passes through the dose setting dial.
 21. The system according to claim 20, wherein the light path between the light source, internal component, and optical sensor also passes through a part of a dose delivery button.
 22. The system according to claim 20, wherein the internal component comprises a pattern of relatively reflective and non-reflecting regions, the pattern of relatively reflective and non-reflecting regions comprising evenly spaced relatively reflective and non-reflecting regions formed on the internal component.
 23. The system according to claim 19, wherein the medicament administration device comprises a housing and wherein the dose setting dial is configured to not rotate relative to the housing when the dose of medicament is delivered from the medicament administration device.
 24. The system according to claim 19, wherein the internal component comprises a plurality of equally spaced crenellations and wherein the reflective regions are formed on upper surfaces of the plurality of crenellations. 